YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 384 drug applications between 20 October 2026 and 26 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 46 drug names.

2026/10/20 – 2026/10/26

Period
2026/10/20 to 2026/10/26, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
384
Drugs with new generic filings (by drug name, de-duplicated)
46
Accepted this week, now under review
361

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

384filings, 60 of them generic

By application type

Application typeFilings
Supplement228
Generic60
New drug51
Import31
Import re-registration9
Unspecified5

By drug type

Drug typeFilings
Chemical drug187
TCM121
Therapeutic biologic67
Biologic6
Prophylactic biologic2
In vitro diagnostic reagent1

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sodium Hyaluronate Eye Drops3230
2Ruxolitinib Phosphate Tablets3127
3Suvorexant Tablets313
4Acetylcysteine Oral Solution2111
5Dotinurad Tablets2155
6环硅酸锆钠散 · No verified English name2112
7苯磺酸美洛加巴林口崩片 · No verified English name212
8西诺氨酯片 · No verified English name2124
9Dapagliflozin Tablets2184
10Dalteparin Sodium Injection212

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

258 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hunan Dong Jian Pharma Co., Ltd. romanized880
2AbbVie Inc.640
3Merck Europe B.V.530
4Medice Arzneimittel Pütter GmbH & Co. KG510
5Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized440
6Shan Tou Shi Shi Dai Pharmaceutical Co., Ltd. romanized440
7Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized440
8Janssen-Cilag International NV430
9Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized430
10Topfond Pharmaceutical Co., Ltd.432

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Entered review this week
149
Left the under-review list this week
425

Of these, NMPA published approval-document delivery for 180 (including 167 supplemental applications, not counted as new marketing approvals) and notification delivery for 11; the outcome of the other 234 is to be checked.

Data collected since 2026/10/22: this week counts snapshots from 2026/10/23 only.

Most filings leaving review, by company

Most filings leaving review, by company
#Company (first applicant)FilingsDrugs
1F. Hoffmann-La Roche Ltd133
2Eli Lilly and Company123
3AstraZeneca AB115
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized83
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized74
6Novo Nordisk A/S73
7Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized62
8Ning Kang Rui Zhu Biopharmaceutical (Zhuhai) Co., Ltd. romanized62
9Shandong Lv Ye Pharmaceutical Co., Ltd. romanized61
10Novartis Pharma AG54

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized44
2Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized44
3Novo Nordisk A/S42
4Zhejiang Er Ying Medicines Co., Ltd. romanized31
5Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized31
6Zuo Jin Ming Pharmaceutical Co., Ltd. romanized22
7Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized22
8Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized22
9Jilin Ji Chun Pharmaceutical Co., Ltd. romanized22
10Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized22

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

90 this week

AcceptedDrugApplicants
2026/10/26Import · Class 1 ABBV-901注射用粉末 · No verified English nameJXSL2600285 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/10/26Import · Class 1 Azenosertib片 · No verified English nameJXHL2600463 K-Group Beta Inc.; Hangzhou Tigermed Consulting Co. Ltd.
2026/10/26Import · Class 1 Azenosertib片 · No verified English nameJXHL2600462 K-Group Beta Inc.; Hangzhou Tigermed Consulting Co. Ltd.
2026/10/26Import · Class 2.4 注射用WCK 5222 · No verified English nameJXHL2600461 Wockhardt Bio AG; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd.
2026/10/26Generic · Class 3 亚硒酸钠注射液 · No verified English nameCYHS2602625 Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized
2026/10/26Generic · Class 3 苯磺酸美洛加巴林口崩片 · No verified English nameCYHS2602617 Topfond Pharmaceutical Co., Ltd.
2026/10/26Generic · Class 3 苯磺酸美洛加巴林口崩片 · No verified English nameCYHS2602616 Topfond Pharmaceutical Co., Ltd.
2026/10/26Generic · Class 3 Suvorexant TabletsCYHL2600124 Guangdong Hao Rui En Pharmaceutical Co., Ltd. romanized
2026/10/26Generic · Class 3 Suvorexant TabletsCYHL2600123 Guangdong Hao Rui En Pharmaceutical Co., Ltd. romanized
2026/10/26Generic · Class 3 Suvorexant TabletsCYHL2600122 Guangdong Hao Rui En Pharmaceutical Co., Ltd. romanized
2026/10/26New drug · Class 2.3 黄葵胶囊 · No verified English nameCXZL2600108 Su Zhong Pharma Group Co., Ltd. romanized
2026/10/26New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSS2600170 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/10/26New drug · Class 1 诺吉仑赛注射液 · No verified English nameCXSS2600169 Shanghai Jun Sai Bio Pharma Co., Ltd. romanized
2026/10/26New drug · Class 1 CM398注射液 · No verified English nameCXSL2601172 Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized
2026/10/26New drug · Class 1 SPGL008注射液 · No verified English nameCXSL2601171 Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized
2026/10/26New drug · Class 1 SSGJ-706注射液 · No verified English nameCXSL2601170 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/10/23Import · Class 2.2 萨特利珠单抗注射液 · No verified English nameJXSS2600098 Roche Pharma (Schweiz) AG; Utsunomiya Plant of Chugai Pharma Manufacturing Co. Ltd.; Roche (China) Holding Ltd.
2026/10/23Import · Class 1 AZD0486 · No verified English nameJXSL2600284 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/23Import · Class 1 AZD0486 · No verified English nameJXSL2600283 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/23Import · Class 1 注射用ABBV-969 · No verified English nameJXSL2600282 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/10/23Import · Class 1 579 - 痤疮 mRNA 注射液 · No verified English nameJXSL2600281 Sanofi Vaccines US Inc.; Shenzhen Sanofi Biological Products Co. Ltd.
2026/10/23Import · Class 2.4 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHS2600132 Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd.
2026/10/23Import · Class 2.4 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHS2600131 Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd.
2026/10/23Generic · Class 3 Betahistine Dihydrochloride TabletsCYHS2602608 Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2026/10/23Generic · Class 3 双氯芬酸依泊胺凝胶贴膏 · No verified English nameCYHL2600121 Hangzhou Duan Ben Pharmaceuticals Technology Co., Ltd. romanized
2026/10/23New drug · Class 1.1 逍遥静音颗粒 · No verified English nameCXZL2600107 Beijing Xin Rui Yuan Pharmaceuticals Technology Co., Ltd. romanized
2026/10/23New drug · Class 2.2 注射用伦康依隆妥单抗 · No verified English nameCXSS2600168 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Name not romanized
2026/10/23New drug · Class 1 泰利奇拜单抗注射液(皮下注射) · No verified English nameCXSS2600167 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2026/10/23New drug · Class 1 IMM040811注射液 · No verified English nameCXSL2601169 Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized
2026/10/23New drug · Class 1 IMM092注射液 · No verified English nameCXSL2601168 Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized

60 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.